Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT05745220
Eligibility Criteria:
Inclusion Criteria:
* The Ocular Surface Disease Index questionnaire (OSDI) score for dry eye classification is ≤ 13
* Participants must be candidates for contact lens wear.
* Corneal radius between 7.4mm and 8.0mm
* If the corneal radius is \> 8.0mm, the corneal diameter must be greater than 12.0mm.
* If the corneal radius is \<7.4mm, the required corneal diameter is less than 12.0mm.
* Participants have a CL cylindrical ametropia ≤ -1.25 D.
* Participants will not have worn CL for 7 days prior to the start of the study.
* Participants do not wear CL regularly (no more than 1 days per week) prior to the start of the study.
* During the study, the participant wore the CL a minimum of 5 days per week for a minimum of 8 hours.
* The person being tested is in good health. This means that he or she does not suffer from any systemic diseases, such as diabetes or rheumatism, which could have an influence on eye health. He or she also has no eye disease and has not previously undergone corneal (refractive) surgery.
Exclusion Criteria:
* The participant is a minor.
* The participant has worn CL within the last 7 days.
* The radius of the cornea is not within the prescribed range. In addition, the corneal diameter is not within the prescribed range either.
* The participant's ametropia is not within the prescribed range.
* The participant has worn the lenses for less than 8 hours for less than five days.
* The participant has no diagnosis of dry eye.
* The OSDI questionnaire score for the Dry Eye classification is greater than 13.
* The participant suffers from a systemic disease (diabetes or rheumatism) that could influence ocular health, an ocular disease or has already undergone refractive surgery.
* Vulnerable participants
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
38 Years
Study:
NCT05745220
Study Brief:
Protocol Section:
NCT05745220